MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 5.5MM STRAIGHT ROD, TITANIUM ALLOY, 125MM LENGTH

Model Number	1119.5125
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.Imaging provided confirmed the rod slipping out of the screw head on the left side.The slippage is consistent with increased instability in the construct following the previously reported screw loosening and screw head pop-off.
Event or Problem Description
It was reported by a representative from japan that a revision surgery was done for a rod that deviated post-operatively.
Event or Problem Description
It was reported by a representative from japan that a revision surgery was done for a rod that deviated post-operatively.
Additional Manufacturer Narrative
Inspection of the subject device found no major defects or damage to the rod.The rod had been cut on one end, and there was no curvature placed in the rod.The slippage is consistent with increased instability in the construct following the previously reported screw loosening and screw head pop-off; however, the exact cause of the reported issue could not be determined.

• Brand Name: CREO
• Common Device Name: 5.5MM STRAIGHT ROD, TITANIUM ALLOY, 125MM LENGTH
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 11689137
• Report Number: 3004142400-2021-00053
• Device Sequence Number: 19726773
• Product Code: MNH
• UDI-Device Identifier: 00889095064339
• UDI-Public: 00889095064339
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1119.5125
• Device Lot Number: CLV618BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other